Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Problems With Drug Absorption Studies Still ‘Relatively Common’ In EU

Inadequacies Have Drawn Major Objections During Initial EMA Review

Executive Summary

A retrospective analysis of new drugs evaluated by the European Medicines Agency since 2010 shows that a lack of, or major deficiencies in, human mass balance studies is still a concern in regulatory submissions.

You may also be interested in...



Ambitious AB Science Gets Masitinib Win For Severe Asthma

Plagued by concerns on the integrity of data and compliance issues with its clinical practices, the French firm still believes masitinib could be effective for ALS, multiple sclerosis, cancers, asthma and even Alzheimer's.

Sticking To Nitrosamine Evaluations Deadline Is Priority For EU Regulators

EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.

Patient Voice Makes Impact In Scientific Advice From EU HTA Network

The EU network of health technology assessment bodies says it is seeing the benefit of systematically involving patients when companies approach it for early scientific advice on evidence generation.

Topics

UsernamePublicRestriction

Register

PS141142

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel